Pulsed Field Ablation: A New Era in AF Treatment
Atrial fibrillation (AF) ablation technology is rapidly advancing, with Pulsed Field Ablation (PFA) emerging as a novel energy source alongside traditional Radiofrequency Ablation (RF).
Our VARIPULSE™ PFA catheter has begun launching with a limited market release in European hospitals, expanding the treatment toolkit for physicians to provide a safe, effective, and efficient solution for treating arrhythmia.
The VARIPULSE™ Platform
The VARIPULSE™ Platform is the first CARTO™-integrated PFA system5. This integration allows for an intuitive and reproducible workflow, delivering real-time visualization and feedback.
The VARIPULSE™ Platform's efficacy and safety were rigorously evaluated in the inspIRE trial, which involved 226 patients across 13 centers in Europe and Canada. The trial demonstrated an impressive 80% freedom from atrial recurrence at 12 months without major adverse events1,2.
Valuable Feedback from Physicians
Working alongside physicians during the commercial evaluation has provided essential insights. Over 40 sites in Europe and Japan performed numerous cases, enhancing the understanding of VARIPULSE™ applications in clinical settings.
Expert Testimonials on VARIPULSE™
Professor Dello Russo*, Ospedale Riuniti Ancona remarked, “We can finally see what we are doing with PFA thanks to the integration with CARTO! Precise applications are now easier due to the clear identification of gaps.”
Dr. Tom De Potter*, M.D., FEHRA, Associate Director, Cardiovascular Center, OLV Hospital, Belgium, noted, "VARIPULSE™ is a straightforward tool that streamlines AF procedures while allowing for flexibility when required."
Understanding Atrial Fibrillation In Europe
AF is the most prevalent cardiac arrhythmia, affecting nearly 50 million people worldwide3 and 11 million in Europe alone4. Access to a comprehensive array of proven ablation techniques is crucial for healthcare providers in addressing this condition.
The Future of Atrial Fibrillation Treatment
The introduction of the VARIPULSE™ Platform marks a significant advancement in the management of atrial fibrillation. With a focus on safety and efficacy, it holds the potential to enhance the treatment landscape for both physicians and patients alike.
References
- Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal AF ablation using a novel variable-loop biphasic pulsed field ablation catheter integrated with a 3D mapping system: 1-year outcomes of the multicenter inspIRE study. Circ Arrhythm Electrophysiol. 2023;16(3):e01178.
- De Potter T, Grimaldi M, Duytschaever M, et al. Predictors of success for pulmonary vein isolation with pulsed field ablation using a variable loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024. doi: 10.1161/CIRCEP.123.012667.
- Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473.
- Global Burden of Disease Collaborative Network (2016) Global Burden of Disease Study 2016 (GBD 2016) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017.
- VARIPULSE Design Trace Matrix Product Requirements: DTMA-0653
*Dr Dello Russo and Dr Tom De Potter were not compensated for their contributions
EM_BWI_THER_391123
© Johnson & Johnson MedTech NV/SA 2024
Important information: Prior to use, refer to the instructions for use supplied with this device
for indications, contraindications, side effects, warnings and precautions.
This publication is not intended for distribution outside of the EMEA region.